The present invention relates to an ostomy appliance for receiving discharge from a human stoma and comprising:                attachment means for attaching the appliance to the peristomal skin surface of a user of the appliance, and        an ostomy pouch assembly comprising:        an inner pouch attached to said attachment means and having a first aperture for receiving the stoma of said user,        said inner pouch being defined by a flexible body side or proximal inner pouch wall and a flexible distal inner pouch wall, and one or more peripherally extending inner pouch sealing seams,        an outer pouch enclosing said inner pouch, attached to said attachment means and having a second aperture for receiving said stoma and being aligned with said first aperture,        said outer pouch being defined by a flexible body side or proximal outer pouch wall and a flexible distal outer pouch wall, and one or more peripherally extending outer pouch sealing seams.        
In connection with the disposal of the pouch assembly or the entire ostomy appliance after use thereof when the inner pouch is more or less full of stomal discharge, it is important that this can be done in a manner that is convenient for the user of the appliance. This entails that it should not be necessary to carry the full inner pouch to a disposal site outside the premises in which the full pouch is to be exchanged with a new, empty pouch. The best solution to this disposal problem is to flush the inner pouch out through a toilet.
Many solutions to this problem have been suggested, for instance in EP 0 703 762, EP 0 611 123, U.S. Pat. No. 4,372,308, GB 2227668, WO 0182846, EP 0 703 762, U.S. Pat. Nos. 5,938,647, 5,769,831 and 5,455,091, the disclosure of which is hereby incorporated herein by reference.
A fully satisfactory solution has not yet been obtained where the inner pouch can easily flow through the sewage system and not cause clogging and overloading of the sewage treatment facilities, where the separation of the inner pouch from the rest of the appliance can be achieved in an easy and secure manner and where the rest of the pouch assembly can be disposed of in a convenient and hygienic manner.
It is a main object of the invention to provide an ostomy appliance where the above listed requirements have been met to a higher degree than before.
According to the invention, this object is achieved by said one or more outer pouch sealing seams being manually peelable such that the attachment forces provided by said one or more peelable outer pouch sealing seams may be manually eliminated by manually pulling said outer pouch wall in a direction transverse to said one or more peelable outer pouch sealing seams.
Hereby, separation forces are applied to said one or more peelable outer pouch sealing seams in a direction transverse thereto so as to peel said outer pouch wall away from the rest of the pouch assembly whereby the inner pouch can be exposed in a simple and convenient manner that does not require any special dexterity.
In the currently preferred embodiment of an ostomy appliance according to the invention, said one or more outer pouch sealing seams peelably attach said distal outer pouch wall to said distal inner pouch wall and said proximal outer pouch wall to said proximal inner pouch wall.
Hereby a particularly simple embodiment is achieved, where the inner pouch sealing seam and the outer pouch sealing seams may be carried out in one single sealing operation.
Alternatively, said one or more outer pouch sealing seams may peelably attach said distal outer pouch wall directly to said proximal outer pouch wall.
Furthermore said one or more outer pouch sealing seams may peelably attach said distal outer pouch wall partly to said proximal outer pouch wall and partly to said distal inner pouch wall and peelably attach said proximal outer pouch wall to said distal outer pouch wall and partly to said proximal inner pouch wall.
In said currently preferred embodiment, the inner pouch is attached to said attachment means by a peelable interior sealing seam extending around said stoma receiving aperture in said inner pouch. Hereby, the inner pouch can be detached from the attachment means in a simple and convenient manner that does not require any special dexterity.
In said currently preferred embodiment, the material of said inner pouch walls is biodegradable. Hereby, the load on the sewage treatment plants is reduced.
In said currently preferred embodiment said inner pouch walls are made of a plastic film laminated to a web of a non-woven fibrous material such as paper, preferably a paper of a toilet tissue type, said web facing outwards relative to the interior of said inner pouch.
Hereby, a particularly efficient and simple manner of obtaining a peelable sealing seam between the inner pouch walls and the outer pouch walls is obtained, and tissue paper readily disintegrates in water so that when discarded into a flush toilet, the fibres of the paper, which are preferably cellulosic and biodegradable, although not soluble in water, quickly disperse.
Furthermore, the use of paper as the outer layer of the inner pouch laminated walls affords important advantages regarding the dry strength of the inner pouch, the soft feel and appearance of the inner pouch and the disposability of the inner pouch by being flushed through a toilet.
Paper in dry condition has a relatively large tensile strength, and thus laminating paper on to a film of plastic material allows using a thinner film for achieving liquid and gas impermeability as well as sufficient combined strength. This is advantageous from an economic viewpoint, as less relatively expensive plastic material is required for the inner pouch walls. However, the main advantage is that the relatively thin film when deprived of the dry strength of the paper after being submerged in water is prone to being broken up into more easily degraded fragments such that the effect on the sewage treatment systems is greatly reduced.
In said currently preferred embodiment, said non-woven material and/or said plastic film are biodegradable.
In said currently preferred embodiment, said inner pouch walls are impermeable to liquid and gas and permeable to odours, and said outer pouch walls are impermeable to liquid, gas and odours. This allows the use of a very thin liquid and gas barrier for the inner pouch walls which is of particular importance for the environmental impact thereof.
Preferably, said one or more outer pouch peeling seams comprises a peeling action initiation zone, where said one or more outer pouch sealing seams comprises a peak-like extent tapering in the direction opposite a predetermined peeling direction. Hereby, the area of the peeling seam where the peeling action is to be initiated is reduced thereby facilitating the peeling operation.
Preferably, said one or more outer pouch peeling seems comprises a peeling action ending zone, where said one or more outer pouch sealing seams comprises a peak-like extent tapering in a predetermined peeling direction. Hereby, the area of the peeling seam where the peeling action is to be ended is reduced thereby facilitating the peeling operation.
Preferably, said interior inner pouch sealing seam comprises a peeling action initiation zone, where interior inner pouch sealing seam comprises a peak-like extent tapering in the direction opposite a predetermined peeling direction, and said interior inner pouch sealing seam comprises a peeling action ending zone, where interior inner pouch sealing seam comprises a peak-like extent tapering in a predetermined peeling direction.
In said currently preferred embodiment, said proximal outer pouch wall is attached to said attachment means by a heat sealed sealing seam. Hereby at least part of the attachment means can be disposed of together with the outer pouch walls.
Alternatively, said proximal outer pouch wall is attached to said attachment means by a peelable sealing seam. Hereby, the attachment means may be disposed of separate from the outer pouch walls.
In one embodiment of a so-called two-piece ostomy appliance according to the invention, said attachment means comprise a face plate assembly comprising a wafer of skin friendly adhesive material having a third aperture for receiving said stoma aligned with said first and second apertures, and a first coupling ring surrounding said third aperture and attached to said wafer and in engagement with a second coupling ring surrounding said first and second apertures and attached to said proximal outer pouch wall and to said proximal inner pouch wall.
In a currently preferred embodiment of a two-piece ostomy appliance according to the invention, said proximal outer pouch wall is attached to said second coupling ring by means of a heat sealed sealing seam. Hereby, the second coupling ring is fixedly attached to the outer pouch wall for disposal therewith.
Advantageously, said proximal inner pouch wall is attached to said second coupling ring by means of said peelable interior sealing seam. Hereby, the inner pouch may be disposed of separately from the second coupling ring.
In said currently preferred embodiment, said proximal inner pouch wall is attached to said proximal outer pouch wall in a region surrounding said first and second apertures by means of said peelable interior sealing seam. Hereby, the inner pouch may be manually separated from the outer pouch in a simple and convenient manner.
In a second embodiment of a two-piece ostomy appliance according to the invention, said attachment means comprise a face plate assembly comprising a wafer of skin friendly adhesive material having a third aperture for receiving said stoma aligned with said first and second apertures, and a first coupling means surrounding said third aperture and attached to said wafer and in releasably adhesive engagement with a second coupling means surrounding said first and second apertures and attached to said proximal outer pouch wall and/or to said proximal inner pouch wall.
The proximal outer pouch wall may attached to said second coupling means by means of a heat sealed sealing seam, and said proximal inner pouch wall may be attached to said second coupling means by means of said peelable interior sealing seam, or said proximal inner pouch wall may be attached to said proximal outer pouch wall in a region surrounding said first and second apertures by means of said peelable interior sealing seam.
In a so-called one-piece ostomy appliance according to the invention, said attachment means comprise a face plate assembly comprising a wafer of skin friendly adhesive material having a fourth aperture for receiving said stoma aligned with said first and second apertures, and a carrier sheet attached to the distal surface of said wafer and attached to said proximal outer pouch wall and to said proximal inner pouch wall.
In a currently preferred embodiment, of a one-piece ostomy appliance according to the invention, said proximal outer pouch wall is attached to said carrier sheet by means of a heat sealed sealing seam.
Advantageously, said proximal inner pouch wall is attached to said carrier sheet by means of said interior peelable sealing seam.
In said currently preferred embodiment, said proximal inner pouch wall is attached to said proximal outer pouch wall in a region surrounding said first and second apertures by means of said peelable interior sealing seam.
In said currently preferred embodiment, said peelable interior sealing seam is constituted by a sheet of film or textile with a fifth stoma receiving aperture and having adhesive on both opposed surfaces. This affords a particularly secure peelable adhesion between the inner pouch and the rest of the appliance.
Advantageously, an annular insert having a sixth aperture for receiving said stoma is provided within said second coupling ring for preventing said stomal discharge from soiling said second coupling ring. Hereby, the second coupling ring can be disposed of in a hygienic manner because it is not soiled by the stomal discharge.
The attachment forces provided by said one or more peelable outer pouch sealing seams are preferably such that the pulling force required for manually eliminating said attachment forces is between approx. 0.5 Newton and approx. 6 Newton, preferably between approx. 0.7 Newton and approx. 5.5 Newton, even more preferably between approx. 0.8 Newton and approx. 5.0 Newton, even more preferably between approx. 0.9 Newton and approx. 4.5 Newton and most preferably between approx. 1.0 Newton and approx. 4.0 Newton.
Hereby the pulling or peeling force is such that the risk of unintended ripping of the outer pouch walls and especially the inner pouch walls is minimal during peeling of the outer pouch sealing seams while the attachment forces are sufficient to ensure the integrity of the pouch assembly during use thereof.
In said currently preferred embodiment, said outer pouch peelable sealing seams are between 4 and 6 mm wide, preferably approximately 5 mm wide. It has turned out that this affords the best balancing of easy peelability and secure fastening of the pouch walls to one another during use of the pouch assembly.
In said currently preferred embodiment, at least a portion the outer peripheral edges of said outer pouch walls and inner pouch walls has been formed by cutting through said walls in the areas of said outer pouch peelable seams. The cutting friction creates a melting zone at the edge of the outer and inner pouches that prevents wicking of water from a shower or bath into the peelable sealing seams containing a fibrous material between the inner pouch walls and the outer pouch walls.
In said currently preferred embodiment, a portion of said outer pouch walls and inner pouch walls extend beyond said outer pouch peelable seams to form inner pouch wall and outer pouch wall gripping tabs for peeling said walls apart. Hereby, a particularly simple and easily implemented peeling function is obtained.
In said currently preferred embodiment, said outer pouch peelable seams are made by applying heat and/or RF to the outer surface of one or both of said outer pouch walls.
In said currently preferred embodiment, an area of each of said inner pouch wall gripping tabs extending into the area covered by the adjacent outer pouch peelable seam has been subjected to application of heat and/or RF prior to the formation of said outer pouch peelable seams. Hereby wicking of water from a shower or a bath is prevented in the region of the tabs into the peelable seams containing a fibrous material between the inner pouch walls and the outer pouch walls.
In said currently preferred embodiment, the fibres of said paper have a generally uniform orientation and said orientation is transversal to a line extending from the top to the bottom of said outer and inner pouches when a user to which said pouches have been applied around a stoma is standing erect, said orientation preferably being generally orthogonal to said line. Hereby, a particularly neat and uniform peeling is obtained where most of the paper remains attached to the inner pouch walls after peeling.
In another aspect, the present invention relates to an ostomy pouch assembly for use in an ostomy appliance according to the invention.
In a further aspect, the present invention relates to an inner pouch for use in an ostomy appliance according to the invention.
In a yet further aspect, the present invention relates to a method of disposing of an ostomy pouch assembly of an ostomy appliance as specified above after use thereof, said method comprising the steps of:                gripping an edge portion of said distal outer pouch wall,        pulling said edge portion of said distal pouch wall away from the body of the user such that the attachment of said distal outer pouch wall by the respective one of said one or more peelable outer pouch sealing seams to the rest of said appliance is disrupted,        gripping mutually superimposed edge portions of said distal and proximal inner pouch wall,        pulling said superimposed edge portions away from the body of the user such that the attachment of said inner pouch by the respective peelable sealing seams to the rest of said appliance is eliminated, and        disposing of the inner pouch with contents in a toilet bowl.        
In a final aspect, the present invention relates to the use of a flexible composite film made of a plastic film laminated to a web of a non-woven fibrous material such as paper, preferably a paper of a toilet tissue type, for providing a peelable sealing seam between an inner pouch and an outer pouch of an ostomy appliance, said inner pouch being surrounded and enclosed by said outer pouch, and the walls of said inner pouch being made of said composite film with said web facing outwards relative to the interior of said inner film.
In the following, the invention will be explained more in detail with reference to various embodiments of the invention shown, solely by way of example, in the drawings.